March 31, 2009
FDA close to approval of brain cancer drug
A U.S. Food and Drug Administration committee is recommending accelerated approval of the drug Avastin for treating brain cancer.
Drug maker Genentech Inc. said the FDA is expected to make a decision next month on use of the colon cancer drug in patients with previously treated glioblastoma, the most aggressive form of brain cancer.The application is based on positive, independently reviewed data from a Phase II study of brain cancer patients. The study found that 43 percent of patients taking Avastin lived six months without their disease getting worse. Half of the patients lived at least 9.3 months and 38 percent lived longer than one year, the company said Tuesday in a release.
Dr. David Schenkein of Genentech said a Phase III trial evaluating Avastin in people with newly diagnosed glioblastoma will be initiated later this year.